Table 1.

Ethical considerations comparison between biomedical and dissemination and implementation research

Ethical considerations	Biomedical research	Dissemination and implementation research
Is it human subjects’ research?	Individuals often serve as subjects, with focus on safety and individual outcomes	Subjects can be individuals, groups, or entire health systems. Ethical review may be needed for interventions affecting broader systems
	Ethical review often focuses on individual participant rights and well-being	Ethical review boards may need to assess impact on communities, organizations, and health delivery systems. Waiving review for quality improvement should be carefully considered
Who should provide informed consent?	Consent typically obtained from individual participants	Consent considerations extend to healthcare providers, administrators, and patients. Scope includes potential impact on systems and practices in implementation
	Consent form outlines study purpose, procedures, risks, and benefits for individuals	Consent may cover changes at the system level, understanding potential effects on multiple stakeholders
Is equipoise necessary?	Control groups often used to compare new interventions	Balancing equipoise can involve changes in practices, necessitating ethical reasoning for control groups. Uncertainty in scientific merit is important, but implementation context adds complexity
	Equipoise considers balancing risks and benefits for individual participants	Risk-benefit assessment includes potential system-level and societal impact, as well as individual well-being
How can scientific rigor be protected in routine care settings?	Rigor focuses on experimental design, data collection, and analysis	Rigor includes evaluating how interventions integrate into real-world contexts. Added challenge of assessing system-level outcomes
	Focus on addressing potential biases from study design and analysis	Consideration of biases extends to the impact of biases on healthcare delivery and system-level outcomes. Balancing scientific rigor with the practical considerations of diverse stakeholders is challenging.